Disposable Circular Stapler
FDA 510(k) clearance K172561 · decided 2017-12-05
Clearance details
- K-number
- K172561
- Device name
- Disposable Circular Stapler
- Applicant
- Changzhou Kangdi Medical Stapler Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-08-25
- Decision date
- 2017-12-05
- Days to decision
- 102 days
- Clearance type
- Special
- Product code
- GDW
- Device class
- 2
- Regulation number
- 878.4750
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Changzhou City, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.